Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT00168818
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '13 weeks', 'description': 'Treatment emergent events (last medication + 3 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.', 'otherNumAtRisk': 1146, 'otherNumAffected': 620, 'seriousNumAtRisk': 1146, 'seriousNumAffected': 89}, {'id': 'EG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.', 'otherNumAtRisk': 1163, 'otherNumAffected': 642, 'seriousNumAtRisk': 1163, 'seriousNumAffected': 91}, {'id': 'EG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.', 'otherNumAtRisk': 1154, 'otherNumAffected': 648, 'seriousNumAtRisk': 1154, 'seriousNumAffected': 82}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 149}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 238}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 258}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 289}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 193}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 185}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 191}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 162}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 60}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 80}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 76}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 81}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Acute right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Feeling hot and cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Inflammation of wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Wound necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 2}, {'groupId': 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'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Prostatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Immobile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Immobilisation prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Air embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arterial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1146, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1154, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '880', 'groupId': 'OG000'}, {'value': '874', 'groupId': 'OG001'}, {'value': '897', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5648', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '1.6', 'pValueComment': 'p-value is for superiority testing', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.'}, {'pValue': '0.1339', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '4.4', 'pValueComment': 'p-value is for superiority testing', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.'}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).\n\nAll of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)'}, {'type': 'SECONDARY', 'title': 'Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}, {'value': '888', 'groupId': 'OG001'}, {'value': '917', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3256', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.8', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}, {'pValue': '0.7052', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.2', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)'}, {'type': 'SECONDARY', 'title': 'Proximal Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '905', 'groupId': 'OG000'}, {'value': '885', 'groupId': 'OG001'}, {'value': '914', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1863', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '0.5', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}, {'pValue': '0.7020', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '2.1', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)'}, {'type': 'SECONDARY', 'title': 'Total Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '874', 'groupId': 'OG000'}, {'value': '871', 'groupId': 'OG001'}, {'value': '894', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3173', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '1.1', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}, {'pValue': '0.1274', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (Percentage)', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '4.3', 'groupDescription': 'Risk difference versus Enoxaparin', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation of independent binomial distribution without stratification', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'Total Deep Vein Thrombosis as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)'}, {'type': 'SECONDARY', 'title': 'Symptomatic Deep Vein Thrombosis During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1137', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}, {'value': '1142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0694', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0212', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op (all patients who are treated and operated)'}, {'type': 'SECONDARY', 'title': 'Pulmonary Embolism During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1137', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}, {'value': '1142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5062', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3717', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op (all patients who are treated and operated)'}, {'type': 'SECONDARY', 'title': 'Death During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1137', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}, {'value': '1142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1240', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2497', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'All cause death, as adjudicated by the VTE events committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - op (all patients who are treated and operated)'}, {'type': 'SECONDARY', 'title': 'Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1106', 'groupId': 'OG000'}, {'value': '1117', 'groupId': 'OG001'}, {'value': '1108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'title': 'Total VTE and all-cause mortality', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'asymptotic Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'symptotic Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary Embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'end of treatment to day 91±7', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with any data available during follow-up'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1146', 'groupId': 'OG000'}, {'value': '1163', 'groupId': 'OG001'}, {'value': '1154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Clinical relevant', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '1005', 'groupId': 'OG000'}, {'value': '1021', 'groupId': 'OG001'}, {'value': '1022', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4352', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6037', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Comparison versus Enoxaparin', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First administration until 31-38 days', 'description': 'Major bleeding events were defined as\n\n* fatal\n* clinically overt associated with loss of haemoglobin \\>=20g/L in excess of what was expected\n* clinically overt leading to the transfusion of \\>=2 units packed cells or whole blood in excess of what was expected\n* symptomatic retroperitoneal, intracranial, intraocular or intraspinal\n* requiring treatment cessation\n* leading to re-operation\n\nClinically-relevant was defined as\n\n* spontaneous skin hematoma greater than or equal to 25 cm²\n* wound hematoma greater than or equal to 100 cm²\n* spontaneous nose bleed lasting longer than 5 min\n* macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention\n* spontaneous rectal bleeding (more than a spot on toilet paper)\n* gingival bleeding lasting longer than 5 min\n* any other bleeding event considered clinically relevant by the investigator\n\nMinor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Blood Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1137', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}, {'value': '1142', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'title': 'Patients with >=1 transfusions', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}, {'value': '542', 'groupId': 'OG002'}]}]}, {'title': 'Patients with >=1 non-autologous transfusions', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Blood transfusion for treated and operated patients on Day of surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Volume of Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1127', 'groupId': 'OG000'}, {'value': '1147', 'groupId': 'OG001'}, {'value': '1133', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '457', 'spread': '304', 'groupId': 'OG000'}, {'value': '435', 'spread': '271', 'groupId': 'OG001'}, {'value': '463', 'spread': '291', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Volume of blood loss for treated and operated patients during surgery.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Laboratory Analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1103', 'groupId': 'OG000'}, {'value': '1098', 'groupId': 'OG001'}, {'value': '1103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'OG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'classes': [{'title': 'AST increase N=(1103;1097;1103)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'AST decrease N=(1103;1097;1103)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT increase N=(1103;1098;1103)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}, {'title': 'ALT decrease N=(1103;1098;1103)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increase N=(1102;1094;1102)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin decrease N=(1102;1094;1102)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First administration to end of study', 'description': 'Frequency of patients with possible clinically significant abnormalities.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'FG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'FG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1146'}, {'groupId': 'FG001', 'numSubjects': '1163'}, {'groupId': 'FG002', 'numSubjects': '1154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1029'}, {'groupId': 'FG001', 'numSubjects': '1054'}, {'groupId': 'FG002', 'numSubjects': '1030'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '124'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '30'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1146'}, {'groupId': 'FG001', 'numSubjects': '1163'}, {'groupId': 'FG002', 'numSubjects': '1154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1013'}, {'groupId': 'FG001', 'numSubjects': '1012'}, {'groupId': 'FG002', 'numSubjects': '1021'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '133'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '31'}]}]}], 'recruitmentDetails': 'The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 28 - 35 days. The study period is from first administration of study medication until day 84 - 91.', 'preAssignmentDetails': 'Whilst 3494 patients were enrolled/randomised to treatment prior to surgery in this trial, only 3463 started treatment. Therefore, 31 patients were randomised but not treated (treatment was planned to start post surgery).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1146', 'groupId': 'BG000'}, {'value': '1163', 'groupId': 'BG001'}, {'value': '1154', 'groupId': 'BG002'}, {'value': '3463', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran 220mg', 'description': 'Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'BG001', 'title': 'Dabigatran 150mg', 'description': 'Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.'}, {'id': 'BG002', 'title': 'Enoxaparin', 'description': 'Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '63.9', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '636', 'groupId': 'BG000'}, {'value': '667', 'groupId': 'BG001'}, {'value': '651', 'groupId': 'BG002'}, {'value': '1954', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '510', 'groupId': 'BG000'}, {'value': '496', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}, {'value': '1509', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index N=(1146;1163;1151;3460)', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '27.8', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '27.5', 'spread': '4.3', 'groupId': 'BG002'}, {'value': '27.7', 'spread': '4.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3494}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-18', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).\n\nAll of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.'}], 'secondaryOutcomes': [{'measure': 'Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee'}, {'measure': 'Proximal Deep Vein Thrombosis During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee'}, {'measure': 'Total Deep Vein Thrombosis During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'Total Deep Vein Thrombosis as adjudicated by the VTE events committee'}, {'measure': 'Symptomatic Deep Vein Thrombosis During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee'}, {'measure': 'Pulmonary Embolism During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee'}, {'measure': 'Death During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'All cause death, as adjudicated by the VTE events committee'}, {'measure': 'Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period', 'timeFrame': 'end of treatment to day 91±7', 'description': 'Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).'}, {'measure': 'Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period', 'timeFrame': 'First administration until 31-38 days', 'description': 'Major bleeding events were defined as\n\n* fatal\n* clinically overt associated with loss of haemoglobin \\>=20g/L in excess of what was expected\n* clinically overt leading to the transfusion of \\>=2 units packed cells or whole blood in excess of what was expected\n* symptomatic retroperitoneal, intracranial, intraocular or intraspinal\n* requiring treatment cessation\n* leading to re-operation\n\nClinically-relevant was defined as\n\n* spontaneous skin hematoma greater than or equal to 25 cm²\n* wound hematoma greater than or equal to 100 cm²\n* spontaneous nose bleed lasting longer than 5 min\n* macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention\n* spontaneous rectal bleeding (more than a spot on toilet paper)\n* gingival bleeding lasting longer than 5 min\n* any other bleeding event considered clinically relevant by the investigator\n\nMinor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.'}, {'measure': 'Blood Transfusion', 'timeFrame': 'Day 1', 'description': 'Blood transfusion for treated and operated patients on Day of surgery.'}, {'measure': 'Volume of Blood Loss', 'timeFrame': 'Day 1', 'description': 'Volume of blood loss for treated and operated patients during surgery.'}, {'measure': 'Laboratory Analyses', 'timeFrame': 'First administration to end of study', 'description': 'Frequency of patients with possible clinically significant abnormalities.'}]}, 'conditionsModule': {'conditions': ['Thromboembolism', 'Arthroplasty, Replacement, Hip']}, 'referencesModule': {'references': [{'pmid': '26578849', 'type': 'DERIVED', 'citation': 'Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.'}, {'pmid': '22995531', 'type': 'DERIVED', 'citation': 'Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.'}, {'pmid': '22709460', 'type': 'DERIVED', 'citation': 'Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.'}, {'pmid': '17869635', 'type': 'DERIVED', 'citation': 'Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Buller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56. doi: 10.1016/S0140-6736(07)61445-7.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nInclusion criteria (selected):\n\n* Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement\n* Written Informed Consent\n\nExclusion criteria\n\nExclusion criteria (selected):\n\n* Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.\n* Active malignant disease or current cytostatic treatment\n* Known severe renal insufficiency\n* Liver disease expected to have any potential impact on survival, or elevated AST or ALT \\> 2x upper limit of normal\n* Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months\n* Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control\n* Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran\n* Contraindications to enoxaparin\n* Participation in a clinical trial during the last 30 days'}, 'identificationModule': {'nctId': 'NCT00168818', 'briefTitle': 'Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. 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